Study of a Novel Thrombectomy Device to Treat Acute Iliofemoral Deep Venous Thrombosis

• Sponsor: Xuzhou Medical University (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT02414802
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Arms: 2
• Duration (Months): 36
• Patients Per Site Per Month: 1.1

Study Details

Study Description

Brief Summary

The purpose of this study is to determine whether the novel aspiration thrombectomy device combined with catheter-directed thrombolysis is effective in the treatment of acute iliofemoral deep venous thrombosis (IF-DVT).

Condition or Disease	Intervention/Treatment	Phase
Venous Thrombosis	Device: a manual spiral thrombus broken suction device; Procedure: catheter-directed thrombolysis; Drug: low-molecular-weight heparin calcium; Drug: urokinase	N/A

Detailed Description

Catheter-directed thrombolysis will be performed in eligible patients with acute IF-DVT. A combined mechanical thrombectomy will be used to clear the iliac thrombi in experimental group. The immediate, mid- and long-term outcomes will be recorded. Quantitative data wiil be expressed as mean ± SD, and will be compared with independent-sample t-test or paired-sample t-test. Count data will be expressed as a ratio (or percentage), and the chi-square test or the fisher's exact test will be used for comparisons. A difference with P < 0.05 will be considered statistically significant. All statistical analyses will be performed using IBM SPSS, version 22.0 (SPSS Inc., Chicago, IL, USA).

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Study on the Application of a Novel Aspiration Thrombectomy Device Combined With Catheter-directed Thrombolysis for the Treatment of Acute Iliofemoral Deep Venous Thrombosis
• Study Start Date: Dec 1, 2014
• Anticipated Primary Completion Date: Dec 1, 2017
• Anticipated Study Completion Date: Dec 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Combined thrombectomy device A manual spiral thrombus broken suction device will be used for thrombectomy before catheter-directed thrombolysis. Ten million U of urokinase once every 4-6 hours will be used during catheter-directed thrombolysis therapy. Anticoagulation therapy will be administered via subcutaneous injection of low-molecular-weight heparin calcium (LMWH-Ca 5,000 U/12 h) at discharge	Device: a manual spiral thrombus broken suction device; A manual spiral thrombus broken suction device will be used for thrombectomy before catheter-directed thrombolysis; Procedure: catheter-directed thrombolysis; catheter-directed thrombolysis will be used in both arms; Drug: low-molecular-weight heparin calcium; anticoagulation therapy will be administered via subcutaneous injection of low-molecular-weight heparin calcium (LMWH-Ca 5,000 U/12 h) in both arms at discharge; Other Names: Low-Molecular-Weight Heparin Calcium for Injection ; Drug: urokinase; A total of 100,000 units urokinase once every 4-6 hours will be used during catheter-directed thrombolysis therapy; Other Names: Urokinase for Injection
Other: Catheter-directed thrombolysis Participants will undergo catheter-directed thrombolysis alone. A total of 100,000 units urokinase will be pulse-spray injected through the catheter once every 4-6 h. Anticoagulation therapy will be administered via subcutaneous injection of low-molecular-weight heparin calcium (LMWH-Ca 5,000 U/12 h) at discharge	Procedure: catheter-directed thrombolysis; catheter-directed thrombolysis will be used in both arms; Drug: low-molecular-weight heparin calcium; anticoagulation therapy will be administered via subcutaneous injection of low-molecular-weight heparin calcium (LMWH-Ca 5,000 U/12 h) in both arms at discharge; Other Names: Low-Molecular-Weight Heparin Calcium for Injection ; Drug: urokinase; A total of 100,000 units urokinase once every 4-6 hours will be used during catheter-directed thrombolysis therapy; Other Names: Urokinase for Injection

Outcome Measures

Primary Outcome Measures

1. patency of lower extremity deep venous [up to 36 months]

   participants will be followed for the duration of hospital stay and will be followed for up to 36 months by lower limb vein color Doppler ultrasonography

Secondary Outcome Measures

1. technical success rate [intraoperation]

   The ratio of successful and total number of participants

2. thrombus removal rate [intraoperation]

   The ratio of preoperative and postoperative thrombosis amount

3. complications [intraoperation]

   a composite outcome measure of observation of whether there is evidences of puncture site hematoma, vascular injury or vascular rupture

4. blood loss [intraoperation]

   The volume of blood loss during operation will be recorded

5. improvement of clinical symptoms and signs [up to 36 months]

   participants will be followed for the duration of hospital stay and will be followed for up to 36 months by clinical examinations

Other Outcome Measures

1. incidence of postthrombotic syndrome [up to 36 months]

   participants will be followed for up to 36 months to observe the incidence of postthrombotic syndrome which is associated with leg swelling, pain, ulceration

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Clinical diagnosis of iliofemoral deep venous thrombosis

• Symptoms of less than 14 days' duration

• With good function status

• A life expectancy of more than 1 year

• A low risk of bleeding

Exclusion Criteria:

• Without iliac vein thrombosis

• Anticoagulation and/or thrombolysis contraindications

• Systemic infection

• Heart, hepatic, renal function insufficiency

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Interventional Radiology and Vascular Surgery, the Affiliated Hospital of Xuzhou Medical College	Xuzhou	Jiangsu	China	221006

Sponsors and Collaborators

• Xuzhou Medical University

Investigators

• Study Director: Qingqiao Zhang, PHD, Xuzhou Medical University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Qianxin Huang, postgraduate student, Xuzhou Medical University
• ClinicalTrials.gov Identifier: NCT02414802
• Other Study ID Numbers: BL2014030
• First Posted: Apr 13, 2015
• Last Update Posted: Jan 18, 2017
• Last Verified: Jan 1, 2017

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Thrombosis; Venous Thrombosis; Calcium, Dietary; Heparin; Calcium heparin; Heparin, Low-Molecular-Weight; Tinzaparin; Dalteparin; Calcium

Study Results

No Results Posted as of Jan 18, 2017